MAUDE Adverse Event Report: MICROVENTION, INC. SCEPTER XC OCCLUSION BALLOON (4X11 MM); BALLOON CATHETER

Model Number	BC0411XC-B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is underway.
Event or Problem Description
It was reported that after positioning a scepter xc balloon in the common carotid artery, the balloon did not inflate.The balloon catheter was removed, and was observed to be broken into two (2) separate pieces.All portions of the balloon were removed from the patient.There was no reported patient injury.The patient was reported to be stable.
Additional Manufacturer Narrative
The device was returned for evaluation.Analysis of the catheter revealed that the proximal 42.5cm of the catheter was noted to be separated from the distal end.Based on the investigation and provided information, the complaint of a separated catheter can be confirmed.The specific root cause of this complaint is unknown, although the device exhibits evidence that rotation of a stopcock over the balloon catheter split through layers of pebax, coils, and the ptfe.

• Brand Name: SCEPTER XC OCCLUSION BALLOON (4X11 MM)
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6488871
• Report Number: 2032493-2017-00087
• Device Sequence Number: 18853694
• Product Code: MJN
• UDI-Device Identifier: 00810170018565
• UDI-Public: (01)00810170018565(11)160920(17)190831(10)16092022
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K113698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2019
• Device Model Number: BC0411XC-B
• Device Lot Number: 16092022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR